NCT04465305

Brief Summary

The subject will treat 68 patients with symptomatic sacral canal cysts as the research object, and adopt a randomized controlled research method, respectively, using two methods of reinforcement and reconstruction of the nerve root sleeve, sacroplasty and nerve root sleeve plasty, and observed the operation of the patient Complications, preoperative and postoperative short-term and long-term VAS pain scores, JOA neural function scores, and changes in cyst size on imaging examinations, to evaluate the safety of nerve root sleeve reconstruction and sacroplasty in reducing the safety of postoperative cyst recurrence Sex and effectiveness, so as to further improve the surgical treatment of sacral canal cysts, improve the curative effect, and formulate the operation specifications for the treatment of sacral canal cyst

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

July 6, 2020

Last Update Submit

July 4, 2021

Conditions

Tarlov Cysts

Keywords

tarlov cysts surgery

Outcome Measures

Primary Outcomes (1)

  • recurrent rate of tarlov cysts

    patents who recurrent postoperation

    1 year

Study Arms (2)

enraped group

EXPERIMENTAL

patients with a new treatment of tarlov cysts

Procedure: entraped treatmentProcedure: plasty treatment

plasty group

ACTIVE COMPARATOR

patients with traditional treatment of tarlov cysts

Procedure: plasty treatment

Interventions

entraped treatmentPROCEDURE

patients with tarlov cysts treated by entraped and plasty nerve root

Also known as: plasty treatment
enraped group
plasty treatmentPROCEDURE

patients with tarlov cysts treated by plasty nerve root

enraped groupplasty group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic nerve root cysts diagnosed by MRI
  • Intact cyst capsule, no defect of sacral canal lamina
  • No other diseases of nervous system, pelvic floor and important organs

You may not qualify if:

  • a ) Non-radiculent cysts or asymptomatic cysts b) Cysts cause severe bone erosion to lamina resorption c) Combined with other diseases of nervous system, pelvic floor and important organs d) Disagree to join e) Cannot complete follow-up -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Haidian, 100191, China

RECRUITING

MeSH Terms

Conditions

Tarlov Cysts

Condition Hierarchy (Ancestors)

CystsNeoplasmsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • liu bin

    Peking University Third Hospital

    STUDY CHAIR

  • wang zhenyu

    Peking University Third Hospital

    STUDY DIRECTOR

  • xie jinchen

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

liu bin

CONTACT

13671027688liubin301@163.com

wu chao

CONTACT

82267358

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 10, 2020

Study Start

July 1, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

July 8, 2021

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)